Luis Velez
Raleigh
Summary
Dynamic Professional with vast experience in the Pharmaceutical and Medical Device Industry. Strong knowledge of GMP’s, GAMP’s, GLP, GDP and FDA regulations. Accurately manages, reviews and safeguards of documentation generated by the project, contractors and suppliers in support of the day-to-day operation of the Turnover Packages in a manner that follows Document Control policies and procedures. This includes, but is not limited to, operating procedures, manuals, engineering/technical reports, test documentation, drawings, correspondence and project management files. Experience on the use of laboratory equipment like pH meters, analytical balances and microscopes. Knowledge of operating manufacturing machines including Hirano coating machine, slicing machine, packaging machine, labelling machine and preventive maintenance. Focus on safety issues, teamwork oriented, analytical and excellent interpersonal and communications skills. Computer literacy in Microsoft Office (Word, Excel, PowerPoint) and Internet. Bilingual English and Spanish.
Overview
19
19
years of professional experience
Work History
Documentation Control Specialist
StartComm Consulting Services
06.2017 - 12.2025
- Responsible for accurate management and safeguarding of documentation generated by the project team, contractors and suppliers in support of the day-to-day operation of the project and in a manner that will enable all relevant parties to quickly retrieve them. This includes, but is not limited to, operating procedures, manuals, engineering/technical reports, correspondence and project management files.
- Control all aspects of project documentation on multiple simultaneous projects, utilizing various control methods/systems.
- Prepare, operate and update Document Control Procedures in line with the Company’s Document Management System.
- Ensure proper document control support is given to each project.
- Produce and maintain Document Progress Reports to Project Managers.
- Ensure all documentation provided is as per Client quality formatting requirements. Formatting may include correcting templates, fonts and style, pagination and numbering and other activities that may be required to achieve a client’s documentation requirements.
- Create Document Control and correspondence folders for individual projects.
- Work in strict co-operation with the Project Manager to ensure project progress status integration.
- Ensure all templates used with the department conform to the Company standard.
- Ad hoc duties as required to assist the project team Responsible for completing and routing documents.
Manufacturing Technician
LifeScan Products LLC, (Johnson & Johnson)
03.2014 - 03.2017
- Responsible for operating machines and preventive maintenance.
- Prepared material to be used in the process and performed material handling.
- Executed inventory transaction in JDE system.
- Assisted modifying procedures to improve equipment operation or processes.
- Provided support for equipment and process validations.
- Performed set-up, clean up, and operation of manufacturing equipment using applicable tools for required adjustments.
- EHS Coordinator
Formulation Technician
LifeScan Products LLC, (Johnson & Johnson)
03.2007 - 03.2014
- Performed all functions related to chemical reagent formulation, mixing process and Hirano machine operation.
- Responsible for solution and enzyme preparation, analytical equipment operation, manufacturing activities (Including machine preparation, analytical equipment operation) and data analysis.
- Provided technical and sustaining support in the areas of troubleshooting, monitoring workflow, 5S program and quality issues resolution.
- Delivered required technical training to other manufacturing team members.
- Performed cycle counts.
- Operated and maintained laboratory equipment for formulation processes.
- Collaborated with cross-functional teams to optimize production workflows.
Education
Some College (No Degree) - Technical Chemistry Engineering
University of Puerto Rico
AreciboSkills
- Safety protocols
- Good manufacturing practices
- Equipment troubleshooting
- Precision assembly
Accomplishments
- Obtained Gold Encore Certificate for completing transfer knowledge training.
- Actively participated in transfer projects and new production’s introduction.
- Yellow Belt Certificate as part of the laboratory team for saving money in the manufacturing process.
Trainings
- Sensors
- 5S Implementation
- Control of Hazardous Energy
Languages
English
Spanish
Timeline
Documentation Control Specialist
StartComm Consulting Services
06.2017 - 12.2025
Manufacturing Technician
LifeScan Products LLC, (Johnson & Johnson)
03.2014 - 03.2017
Formulation Technician
LifeScan Products LLC, (Johnson & Johnson)
03.2007 - 03.2014
Some College (No Degree) - Technical Chemistry Engineering
University of Puerto Rico